Sinochem Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3013249698 • Nanjing, Jiangsu • CHINA
FEI Number
3013249698
Location
Nanjing, Jiangsu
Country
CHINAAddress
Fls 21, Jin Cheng Tower, NO. 216 Middle Longpan Road, Nanjing, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
Frequently Asked Questions
What is Sinochem Pharmaceutical Co., Ltd.'s FDA import refusal history?
Sinochem Pharmaceutical Co., Ltd. (FEI: 3013249698) has 3 FDA import refusal record(s) in our database, spanning from 9/18/2014 to 2/3/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sinochem Pharmaceutical Co., Ltd.'s FEI number is 3013249698.
What types of violations has Sinochem Pharmaceutical Co., Ltd. received?
Sinochem Pharmaceutical Co., Ltd. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Sinochem Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Sinochem Pharmaceutical Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.